MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH PRE-LORDOSED ROD W/LINE 55MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number	179771055
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-codes: mni, nkb, kwp, kwq, osh.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
On or about (b)(6) 2019 the surgeon performed a l5-s1 laminectomy and decompression with l5-s1 fusion on patient at (b)(6) hospital in (b)(6).Shortly after the surgery, the patient complained of tightness and a pulling sensation in his left leg and sharp pain in his left hip and back of his left leg.On or about (b)(6) 2019, patient's ct of lumbar spine showed that the l5 pedicle screw had deviated laterally out the side of the vertebral body and was in close contact with a nearby nerve root.On or about (b)(6) 2019, surgeon performed a l5-s1 fusion exploration on patient and attempted to reposition the l5 pedicle screw more laterally.When the l5 screw could not be repositioned, both the l5 and s1 pedicle screws were removed, however due to improper placement of the l5 pedicle screw patient suffered progressive and permanent nerve damage resulting to chronic pain and weakness and loss function in his left lower extremity.Concomitant device reported: single-inner setscrew (part # 179702000, lot # unknown, quantity# 1); si polyaxl screw 7 x 45mm (part # 179712745 , lot # unknown, quantity# 1); si polyaxl screw 7 x 35mm (part # 179712735, lot # unknown, quantity# 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: PRE-LORDOSED ROD W/LINE 55MM
• Common Device Name: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12097522
• Report Number: 1526439-2021-01370
• Device Sequence Number: 4215577
• Product Code: MNH
• UDI-Device Identifier: 10705034077598
• UDI-Public: (01)10705034077598
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: PREADM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 179771055
• Device Catalogue Number: 179771055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention